The purpose of this protocol is to determine whether pain with sexual intercourse can be reduced in menopausal, breast cancer survivors and to evaluate the effectiveness of a non-hormonal therapy (Lidocaine Liquid) vs. a placebo liquid in reducing pain.

The investigators hypothesize that the pain arises in the vulvar vestibule. The investigators predict that the localized use of lidocaine will be more efficacious than use of placebo liquid.

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:

Entry dyspareunia relief [ Time Frame: From the date of enrollment to 6 months ] [ Designated as safety issue: No ]

Decrease in reported pain by subjects on McGill Pain Questionnaire.

Secondary Outcome Measures:

Improvement of quality of sexual life. [ Time Frame: From time of enrollment until 6 months later ] [ Designated as safety issue: No ]

To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by improved scores on the Female Sexual Distress Scale and the Sexual Function Questionnaire.

Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule

Placebo Comparator: Topical Saline

Drug: Topical liquid lidocaine

Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule

Detailed Description:

For this study there will be three visits over a 3 month period. Subjects will undergo a gynecological exam at the screening visit to determine the severity of pain associated with uncomfortable intercourse. A touch test using Q-tips will be used during screening exam so subjects can report pain during application of both study drug and placebo. Subjects will also report pain during tampon test. A sample of vaginal cells and liquid will be obtained at screening visit so that PI can rule out possible infection, disease, or disorders. PI will also show subject the area of the vestibule in a mirror so that subject can apply study drug at home properly. Subjects will fill out 4 questionnaires about medical and health history, cancer history, pain, and distress and sexual activity. Subject will be given a supply of either study drug or placebo to take home. The first visit will last approximately 2 hours.

Subjects will return for a second visit after 4 weeks and a third visit after 8 weeks for diary review, questionnaires, and examination. The second and third visit examinations will be repeats of the examination done at the first visit, but there will be no comparison with placebo, the PI will use only study drug during the touch test. The second and third visits will last approximately 1 hour.

Has a previous diagnosis of breast cancer (ductal or lobular carcinoma, invasive).

1 year from diagnosis of breast cancer.

Stable heterosexual partnership =/>5 years or by investigator discretion.

More than 6 months of consistent insertional pain with intercourse (may have stopped having intercourse due to this consistent experience of pain).

Menopausal, demonstrated by at least one of the following:

i. cessation of menses for 1 years ii. Bilateral oophorectomy iii. FSH level >25 in women below age 50 with an ovary and scarred or absent uterus (acceptable FSH levels can be inferred if the woman's oncologist monitors FSH during aromatase inhibitor therapy).

Potential subject has used topical or systemic estrogen within the last 4 months.

Has continued tenderness of vestibule mucosa immediately after application of both test liquids.

Allergy to lidocaine or other numbing agents.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01539317